Positive indications – studies and publications

Ongoing & Planned Clinical Studies

• The randomized controlled PM007 study saw the last subject leaving the study at the end of July 2022. A manuscript for a scientific article will be submitted for publication at the end of October 2022 at the earliest. The study recruited approximately 132 subjects with chronic migraine and was conducted at nine clinics in Germany and Finland. the primary endpoint was the reduction of headache days, and it was achieved with statistical significance. Sub group data (from the 97 German patients) was presented at MTIS 2022 in London.

  Hoffmann et al. (2022) Kinetic Oscillation Stimulation for the treatment of chronic migraine – a subgroup analysis of a randomised controlled clinical trial

• The study on chronic rhinitis PR008 completed the clean data file in June 2022, analysis and publication work is now underway.
  
  
• The PM009 study is a planned, open pilot study to evaluate the efficacy of intranasal kinetic oscillation stimulation (K.O.S) in the preventive treatment of chronic migraine on subjects not responding to treatment with monoclonal antibodies targeting the CGRP pathway. The study aimed to include 25-30 subjects to investigate the reduction of headache days using the KOS technology. Blood samples will be evaluated for relevant biomarkers.
  The study is conducted at King’s College in London with three to four referring clinics assisting with the recruitment of suitable subjects for the study. The objective with this investigation is to detect a potential positive effect. Any level of positive result will likely mean a great opportunity for our company as this challenged patient group has very few options left.
  
  
• The PM010 study is a planned, open post-marketing clinical follow-up investigation to follow long-term performance and safety of intranasal kinetic oscillation in subjects with chronic migraine during regular clinical treatment. The study will recruit 200 subjects and will be conducted at approximately 15 clinics in three to four European countries, the follow-up is 12 months. Data from this open study will be reported in intervals and used to fine-tune recommendations for the clinical regime.

Clinical studies and references

The effect of Chordate’s treatment has been investigated in a number of studies over the years, where Chordate has often been the sponsor. These studies have been published in the articles below.

Migraine – studies with K.O.S

Hoffmann J. et al.  Kinetic Oscillation Stimulation for the treatment of chronic migraine – a subgroup analysis of a randomised controlled clinical trial. Cephalalgia. 2022 [MTIS22-LBA-016]. Volume 42, Issue 1_suppl: 112 – 139

Tie-Qiang Li, Yanlu Wang, Rolf Hallin, Jan-Erik Juto. Resting-state fMRI study of acute migraine treatment with kinetic oscillation stimulation in nasal cavity. Neurolmage: Clinical 2016; 451-459

Jan-Erik Juto, MSc, MD, PhD; Rolf G. Hallin, MD, PhD. Kinetic Oscillation Stimulation as Treatment of Acute Migraine: A Randomized, Controlled Pilot Study. Wiley Periodicals, Inc. 2014

Rhinitis / Nasal congestion – studies with K.O.S

Lino Di Rienzo Businco, Marco Radici, Pasquale Longo, Fausto Carru, Andrea Di Rienzo Businco (2023) Effectiveness of Kinetic Oscillation Stimulation Treatment in Persistent Moderate-severe Allergic Rhinitis Compared to Medical Therapy. Journal of Otolaryngology Research & Reports. 2023(2)112

Sainio, S, Blomgren, K, Laulajainen-Hongisto, A, Lundberg, M. The effect of single kinetic oscillation stimulation treatment on nonallergic rhinitis. Laryngoscope Investigative Otolaryngology. 2023; 8( 2): 373– 379.

Monti G, Seccia V, Berrettini S, Picariello M, Gramellini G, et al. (2022) Clinical Results of Kinetic Oscillation Stimulation (K.O.S.) in Non-Allergic Rhinitis. J Clin Res Med Volume 5(3): 1–4. DOI: 10.31038/JCRM.2022532

Tortorella F, Effectiveness of Kinetic Oscillation Stimulation Treatment in Patients with Non-Allergic Rhinitis Refractory to Conventional Medical Therapies. Ame J Surg Clin Case Rep. 2022; 4(4): 1-7

Nacie Bello Petersen and Knud Larsen. “Kinetic Oscillation Stimulation of Nasal Mucosa as Treatment for Non-allergic Rhinitis. A Pilot Study”. Acta Scientific Otolaryngology 3.1 (2021): 39-42.

Fokkens et al. The Effect Of Kinetic Oscillation Stimulation On Symptoms Of Non-Allergic Rhinitis: A Per-Protocol Analysis Of A Randomized Controlled Trial. Journal of Otolaryngology Head & Neck Surgery, May 15, 2020 DOI:10.24966/OHNS-010X/100042

Fokkens et al. Rhinology Future Debates 2017 by EUFOREA: Novel treatments and surgical solutions in rhinology. Clinical Otolaryngology. 2018;1–10.

Ehnhage, A, Sahlstrand Johnsson P, et al Treatment of idiopathic rhinitis with kinetic oscillations – a multi- centre randomized controlled study. Acta Oto-laryngologica, 2016; 136(8):852-859

Studierapport PR003: A clinical investigation of Kinetic Oscillation Stimulation by the PBASE system in the treatment of Idiopathic Rhinitis (KOSIR), 2015

Juto JE, Axelsson M. Kinetic oscillation stimulation as treatment of non-allergic rhinitis: an RCT study. Acta Otolaryngol 2014; 134:506-12.

Mechanism of action

Markus Jerling MD, Iwona Cygankiewicz, Nabil Al-Tawil, Borje Darpo, Anders Ljungström, Wojciech Zareba. Effects of intranasal kinetic oscillation stimulation on heart rate Variability. Ann Noninvasive Electrocardiol. 2017;e12474.

Tie-Qiang Li, Yanlu Wang, Rolf Hallin, Jan-Erik Juto. Resting-state fMRI study of acute migraine treatment with kinetic oscillation stimulation in nasal cavity. NeuroImage: Clinical 12 (2016) 451–459

Other scientific references

Sarin S. The role of the nervous system in rhinitis. J Allergy Clin Immunol 2006; 118:999-1016.

Safwan S. Jaradeh, MD; Timothy L. Smith, MD, MPH; Laura Torrico, MD; Thomas E. Prieto, PhD; Todd A. Loehrl, MD; Ronald J. Darling, MD; Robert J. Toohill, MD, FACS. Autonomic Nervous System Evaluation of Patients With Vasomotor Rhinitis. Laryngoscope 2000; 110:1828–1831

Hellings P.W., Klimek L., Cingi C., Agache I., Akdis C., Bachert C., Bousquet J., Demoly P., Gevaert P., Hox V., Hupin C., Kalogjera L., Manole F., Mösges R., Mullol J., Muluk N.B., Muraro A. , Papadopoulos N., Pawankar R. , Rondon C. , Rundenko M., Seys S.F., Toskala E., Van Gerven L., Zhang L., Zhang N., Fokkens W.J. Non-Allergic Rhinitis: Position paper of the European Academy of Allergology and Clinical Immunology. Allergy. 2017

K. Scadding, H. H. Kariyawasam, G. Scadding, R. Mirakian, R. J. Buckley, T. Dixon, S. R. Durham, S. Farooque, N. Jones, S. Leech, S. M. Nasser, R. Powell, G. Roberts, G. Rotiroti, A. Simpson, H. Smith, A. T. Clark, BSACI guideline for the diagnosis and management of allergic and non-allergic rhinitis (Revised Edition 2017; First edition 2007), Clin Exp Allergy. 2017;47:856–889.

Pete Smith, David Price, Richard Harvey, Andrew Simon Carney, Vicky Kritikos, Sinthia Z Bosnic-Anticevich, Louise Christian, Derek Skinner, Victoria Carter, Alice Marie Sybille Durieux. Medication-related costs of rhinitis in Australia: a NostraData cross sectional study of pharmacy purchases. Journal of Asthma and Allergy. 2017:10 153–161